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Retrospective Chart Review of Patients With Acanthamoeba Keratitis Who Have Received 0.8 mg/ml Polihexanide

NCT06641882 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2025-10-01

No results posted yet for this study

Summary

This will be a non-interventional study with secondary use of data. The study will be a site-based retrospective review of medical chart of patients with AK who initiated and completed a treatment with 0.8 mg/ml polihexanide as part of a compassionate use program. Patientlevel data will be abstracted from medical chart of eligible patients at participating sites and imputed in an electronic case report form (eCRF). Baseline (Time 0) is the date of initiation of 0.8 mg/ml polihexanide. The study period is the period from T0 to the end of treatment. The clinical outcome needs to be confirmed at least 30 days after the conclusion of the treatment.

Conditions

  • Acanthamoeba Keratitis

Sponsors & Collaborators

  • SIFI SpA

    lead INDUSTRY

Principal Investigators

  • Karl Knutsson, MD · San Raffaele Scientific Institute

Eligibility

Min Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-30
Primary Completion
2025-09-01
Completion
2025-09-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06641882 on ClinicalTrials.gov